Trial in HPV Prevention for the U.S. Vietnamese Community (HERO)

Applying the Multiphase Optimization Strategy to Develop and Test a Culturally-Relevant Digital Health Intervention Targeting HPV Vaccination Among U.S. Vietnamese

The purpose of the HERO study is to leverage the Multiphase Optimization Strategy (MOST) framework to conduct a pilot trial testing four different intervention components (expert video, self-persuasion, narrative storytelling, and motivational interviewing) targeting HPV vaccination among U.S. Vietnamese.

PRIMARY AIM To assess the feasibility and acceptability of each of the four digital HERO intervention components in a pilot optimization trial using the MOST framework. Using a highly efficient design, the study team will randomize 96 Vietnamese parents of unvaccinated adolescents to receive 0 to 4 HERO components. The study team will establish the feasibility (reach, retention, adherence) and acceptability (usability, satisfaction, usefulness, cultural relevance) of each component (expert video, self-persuasion, narrative storytelling, and motivational interviewing).

SECONDARY AIM To investigate effects of each component on HPV vaccination outcomes and psychosocial mediators. The study team will examine the effects on HPV vaccination (initiation and intention) and psychosocial mediators.

Study Overview

• Status: Recruiting
• Conditions: HPV Vaccination; HPV-related Cancers
• Intervention / Treatment: Behavioral: Expert Video; Behavioral: Self-persuasion; Behavioral: Narrative Storytelling; Behavioral: Motivational Interviewing; Behavioral: Constant Component

Detailed Description

The purpose of the HERO study is to leverage the Multiphase Optimization Strategy (MOST) framework to conduct a pilot trial testing four different intervention components (expert video, self-persuasion, narrative storytelling, and motivational interviewing) targeting HPV vaccination among U.S. Vietnamese.

PRIMARY AIM To assess the feasibility and acceptability of each of the four digital HERO intervention components in a pilot optimization trial using the MOST framework. Using a highly efficient design, the study team will randomize 96 Vietnamese parents of unvaccinated adolescents to receive 0 to 4 HERO components. The study team will establish the feasibility (reach, retention, adherence) and acceptability (usability, satisfaction, usefulness, cultural relevance) of each component (expert video, self-persuasion, narrative storytelling, and motivational interviewing).

SECONDARY AIM To investigate effects of each component on HPV vaccination outcomes and psychosocial mediators. The study team will examine the effects on HPV vaccination (initiation and intention) and psychosocial mediators.

Research participants will be identified and recruited through online recruitment, community organizations, social media, research team social networks and personal contacts, and in-person events targeting U.S. Vietnamese parents of adolescents. Interested potential participants will answer an online screener for eligibility. When appropriate, potential participants can also be screened via a brief Zoom, telephone, or in-person interview. Once a participant is determined to be eligible for study participation, the study team will communicate via telephone or send a follow up email to them to invite them to participate in the research. Participants will provide eConsent via a form hosted on REDCap, including accepting that the interviews will be audio and/or video recorded. After consent is received, all additional study procedures will be handled by the study team.

Assessments. Participants will also fill out a short survey that captures sociodemographic information and vaccine beliefs and attitudes. This short survey cannot be completed until after participants have consented to participate. Participants will complete follow-up assessments at 1, 3, and 6 months post-baseline, including a survey and interview at Month 1 and surveys at Months 3 and 6.

Randomization and Study Orientation. Following the completion of the baseline assessment, participants will be randomized using computer-generated randomly permuted blocks, stratified by the sex of the adolescent (to acknowledge historical differences in HPV uptake among male and female adolescents). All participants will receive the constant component through the study website. Depending on the intervention condition, participants will receive 0 to 4 intervention components and complete them within 4 weeks from the baseline assessment.

Intervention Components

Constant component: Each participant will receive the constant component through the study website, which includes a vaccine information statement from the CDC with details on HPV vaccine benefits, potential side effects, and recommended vaccination schedule, as well as online information on access and locations for HPV vaccine (e.g., list of Vaccines for Children providers where Medicaid, uninsured, or underinsured adolescents can be vaccinated for free).

Expert video: Participants will watch a video featuring Vietnamese healthcare providers. In the video, the providers will endorse vaccine safety and efficacy, dispel common misconceptions or concerns, and use verbal persuasion techniques to recommend HPV vaccination.

Self-persuasion: Participants will complete an interactive web-based task where they audio record reasons, summarized in their own words, for getting their adolescent the HPV vaccine.

Narrative storytelling: Participants will watch a video featuring U.S. Vietnamese parents. In the video, featured parents will describe stories of their experiences learning about the HPV vaccine as well as motivations to initiate and complete the vaccine series on-time for their adolescents.

Motivational interviewing: Participants will receive 2 calls (phone or Zoom) from a trained U.S. Vietnamese health educator. The health educator will use motivation interviewing (e.g., open-ended questions, acknowledging feelings, affirmations, reflective listening) to increase opportunities for and commitment to HPV vaccination while decreasing barriers (e.g., safety or access concerns).

Participants will be followed for a maximum of 6 months from the baseline assessment and will complete up to 3 additional assessments (1-month, 3-month, and 4-month post-randomization).

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Milkie Vu; Phone Number: 312-503-6592; Email: milkie.vu@northwestern.edu
• Study Contact Backup: Name: Ninh Nguyen; Email: ninh.nguyen@northwestern.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern University
      • Contact: Milkie Vu; Phone Number: 312-503-6592; Email: milkie.vu@northwestern.edu
      • Contact: Ninh Nguyen; Email: ninh.nguyen@northwestern.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Self-identify as U.S. Vietnamese.
• Are the parent of a youth ages 9-18 who have not initiated the HPV vaccine series. Only one parent per household will be able to participate.
• Have lived in the U.S. for 12 months or more.

Exclusion Criteria:

• Planning to move out of the U.S. within the next 6 months.
• Not fluent in either spoken and written Vietnamese or spoken and written English.
• Inability to provide informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

16

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Exp Condition 1; Research participant receives the Constant component + Expert video + Self-persuasion + Narrative storytelling + Motivational interviewing	Behavioral: Expert Video; Participants will watch a video featuring Vietnamese healthcare providers. In the video, the providers will endorse vaccine safety and efficacy, dispel common misconceptions or concerns, and use verbal persuasion techniques to recommend HPV vaccination.; Behavioral: Self-persuasion; Participants will complete an interactive web-based task where they audio record reasons, summarized in their own words, for getting their adolescent the HPV vaccine.; Behavioral: Narrative Storytelling; Participants will watch a video featuring U.S. Vietnamese parents. In the video, featured parents will describe stories of their experiences learning about the HPV vaccine as well as motivations to initiate and complete the vaccine series on-time for their adolescents.; Behavioral: Motivational Interviewing; Participants will receive 2 calls (phone or Zoom) from a trained U.S. Vietnamese health educator. The health educator will use motivation interviewing (e.g., open-ended questions, acknowledging feelings, affirmations, reflective listening) to increase opportunities for and commitment to HPV vaccination while decreasing barriers (e.g., safety or access concerns).; Behavioral: Constant Component; Each participant will receive the constant component through the study website, which includes a vaccine information statement from the CDC with details on HPV vaccine benefits, potential side effects, and recommended vaccination schedule, as well as online information on access and locations for HPV vaccine (e.g., list of Vaccines for Children providers where Medicaid, uninsured, or underinsured adolescents can be vaccinated for free).
Experimental: Experimental: Exp Condition 2; Research participant receives Constant + Expert video + Self-persuasion + Narrative storytelling.	Behavioral: Expert Video; Participants will watch a video featuring Vietnamese healthcare providers. In the video, the providers will endorse vaccine safety and efficacy, dispel common misconceptions or concerns, and use verbal persuasion techniques to recommend HPV vaccination.; Behavioral: Self-persuasion; Participants will complete an interactive web-based task where they audio record reasons, summarized in their own words, for getting their adolescent the HPV vaccine.; Behavioral: Narrative Storytelling; Participants will watch a video featuring U.S. Vietnamese parents. In the video, featured parents will describe stories of their experiences learning about the HPV vaccine as well as motivations to initiate and complete the vaccine series on-time for their adolescents.; Behavioral: Constant Component; Each participant will receive the constant component through the study website, which includes a vaccine information statement from the CDC with details on HPV vaccine benefits, potential side effects, and recommended vaccination schedule, as well as online information on access and locations for HPV vaccine (e.g., list of Vaccines for Children providers where Medicaid, uninsured, or underinsured adolescents can be vaccinated for free).
Experimental: Experimental: Exp Condition 3; Research participant receives Constant + Expert video + Self-persuasion + Motivational interviewing	Behavioral: Expert Video; Participants will watch a video featuring Vietnamese healthcare providers. In the video, the providers will endorse vaccine safety and efficacy, dispel common misconceptions or concerns, and use verbal persuasion techniques to recommend HPV vaccination.; Behavioral: Self-persuasion; Participants will complete an interactive web-based task where they audio record reasons, summarized in their own words, for getting their adolescent the HPV vaccine.; Behavioral: Motivational Interviewing; Participants will receive 2 calls (phone or Zoom) from a trained U.S. Vietnamese health educator. The health educator will use motivation interviewing (e.g., open-ended questions, acknowledging feelings, affirmations, reflective listening) to increase opportunities for and commitment to HPV vaccination while decreasing barriers (e.g., safety or access concerns).; Behavioral: Constant Component; Each participant will receive the constant component through the study website, which includes a vaccine information statement from the CDC with details on HPV vaccine benefits, potential side effects, and recommended vaccination schedule, as well as online information on access and locations for HPV vaccine (e.g., list of Vaccines for Children providers where Medicaid, uninsured, or underinsured adolescents can be vaccinated for free).
Experimental: Experimental: Exp Condition 4; Research participant receives Constant + Expert video + Self-persuasion	Behavioral: Expert Video; Participants will watch a video featuring Vietnamese healthcare providers. In the video, the providers will endorse vaccine safety and efficacy, dispel common misconceptions or concerns, and use verbal persuasion techniques to recommend HPV vaccination.; Behavioral: Self-persuasion; Participants will complete an interactive web-based task where they audio record reasons, summarized in their own words, for getting their adolescent the HPV vaccine.; Behavioral: Constant Component; Each participant will receive the constant component through the study website, which includes a vaccine information statement from the CDC with details on HPV vaccine benefits, potential side effects, and recommended vaccination schedule, as well as online information on access and locations for HPV vaccine (e.g., list of Vaccines for Children providers where Medicaid, uninsured, or underinsured adolescents can be vaccinated for free).
Experimental: Experimental: Exp Condition 5; Research participant receives Constant + Expert video + Narrative storytelling + Motivational interviewing	Behavioral: Expert Video; Participants will watch a video featuring Vietnamese healthcare providers. In the video, the providers will endorse vaccine safety and efficacy, dispel common misconceptions or concerns, and use verbal persuasion techniques to recommend HPV vaccination.; Behavioral: Narrative Storytelling; Participants will watch a video featuring U.S. Vietnamese parents. In the video, featured parents will describe stories of their experiences learning about the HPV vaccine as well as motivations to initiate and complete the vaccine series on-time for their adolescents.; Behavioral: Motivational Interviewing; Participants will receive 2 calls (phone or Zoom) from a trained U.S. Vietnamese health educator. The health educator will use motivation interviewing (e.g., open-ended questions, acknowledging feelings, affirmations, reflective listening) to increase opportunities for and commitment to HPV vaccination while decreasing barriers (e.g., safety or access concerns).; Behavioral: Constant Component; Each participant will receive the constant component through the study website, which includes a vaccine information statement from the CDC with details on HPV vaccine benefits, potential side effects, and recommended vaccination schedule, as well as online information on access and locations for HPV vaccine (e.g., list of Vaccines for Children providers where Medicaid, uninsured, or underinsured adolescents can be vaccinated for free).
Experimental: Experimental: Exp Condition 6; Research participant receives Constant + Expert video + Narrative storytelling	Behavioral: Expert Video; Participants will watch a video featuring Vietnamese healthcare providers. In the video, the providers will endorse vaccine safety and efficacy, dispel common misconceptions or concerns, and use verbal persuasion techniques to recommend HPV vaccination.; Behavioral: Narrative Storytelling; Participants will watch a video featuring U.S. Vietnamese parents. In the video, featured parents will describe stories of their experiences learning about the HPV vaccine as well as motivations to initiate and complete the vaccine series on-time for their adolescents.; Behavioral: Constant Component; Each participant will receive the constant component through the study website, which includes a vaccine information statement from the CDC with details on HPV vaccine benefits, potential side effects, and recommended vaccination schedule, as well as online information on access and locations for HPV vaccine (e.g., list of Vaccines for Children providers where Medicaid, uninsured, or underinsured adolescents can be vaccinated for free).
Experimental: Experimental: Exp Condition 7; Research participant receives Constant + Expert video + Motivational interviewing	Behavioral: Expert Video; Participants will watch a video featuring Vietnamese healthcare providers. In the video, the providers will endorse vaccine safety and efficacy, dispel common misconceptions or concerns, and use verbal persuasion techniques to recommend HPV vaccination.; Behavioral: Motivational Interviewing; Participants will receive 2 calls (phone or Zoom) from a trained U.S. Vietnamese health educator. The health educator will use motivation interviewing (e.g., open-ended questions, acknowledging feelings, affirmations, reflective listening) to increase opportunities for and commitment to HPV vaccination while decreasing barriers (e.g., safety or access concerns).; Behavioral: Constant Component; Each participant will receive the constant component through the study website, which includes a vaccine information statement from the CDC with details on HPV vaccine benefits, potential side effects, and recommended vaccination schedule, as well as online information on access and locations for HPV vaccine (e.g., list of Vaccines for Children providers where Medicaid, uninsured, or underinsured adolescents can be vaccinated for free).
Experimental: Experimental: Exp Condition 8; Research participant receives Constant + Expert video	Behavioral: Expert Video; Participants will watch a video featuring Vietnamese healthcare providers. In the video, the providers will endorse vaccine safety and efficacy, dispel common misconceptions or concerns, and use verbal persuasion techniques to recommend HPV vaccination.; Behavioral: Constant Component; Each participant will receive the constant component through the study website, which includes a vaccine information statement from the CDC with details on HPV vaccine benefits, potential side effects, and recommended vaccination schedule, as well as online information on access and locations for HPV vaccine (e.g., list of Vaccines for Children providers where Medicaid, uninsured, or underinsured adolescents can be vaccinated for free).
Experimental: Experimental: Exp Condition 9; Research participant receives Constant + Self-persuasion + Narrative storytelling + Motivational interviewing	Behavioral: Self-persuasion; Participants will complete an interactive web-based task where they audio record reasons, summarized in their own words, for getting their adolescent the HPV vaccine.; Behavioral: Narrative Storytelling; Participants will watch a video featuring U.S. Vietnamese parents. In the video, featured parents will describe stories of their experiences learning about the HPV vaccine as well as motivations to initiate and complete the vaccine series on-time for their adolescents.; Behavioral: Motivational Interviewing; Participants will receive 2 calls (phone or Zoom) from a trained U.S. Vietnamese health educator. The health educator will use motivation interviewing (e.g., open-ended questions, acknowledging feelings, affirmations, reflective listening) to increase opportunities for and commitment to HPV vaccination while decreasing barriers (e.g., safety or access concerns).; Behavioral: Constant Component; Each participant will receive the constant component through the study website, which includes a vaccine information statement from the CDC with details on HPV vaccine benefits, potential side effects, and recommended vaccination schedule, as well as online information on access and locations for HPV vaccine (e.g., list of Vaccines for Children providers where Medicaid, uninsured, or underinsured adolescents can be vaccinated for free).
Experimental: Experimental: Exp Condition 10; Research participant receives Constant + Self-persuasion + Narrative storytelling	Behavioral: Self-persuasion; Participants will complete an interactive web-based task where they audio record reasons, summarized in their own words, for getting their adolescent the HPV vaccine.; Behavioral: Narrative Storytelling; Participants will watch a video featuring U.S. Vietnamese parents. In the video, featured parents will describe stories of their experiences learning about the HPV vaccine as well as motivations to initiate and complete the vaccine series on-time for their adolescents.; Behavioral: Constant Component; Each participant will receive the constant component through the study website, which includes a vaccine information statement from the CDC with details on HPV vaccine benefits, potential side effects, and recommended vaccination schedule, as well as online information on access and locations for HPV vaccine (e.g., list of Vaccines for Children providers where Medicaid, uninsured, or underinsured adolescents can be vaccinated for free).
Experimental: Experimental: Exp Condition 11; Research participant receives Constant + Self-persuasion + Motivational interviewing	Behavioral: Self-persuasion; Participants will complete an interactive web-based task where they audio record reasons, summarized in their own words, for getting their adolescent the HPV vaccine.; Behavioral: Motivational Interviewing; Participants will receive 2 calls (phone or Zoom) from a trained U.S. Vietnamese health educator. The health educator will use motivation interviewing (e.g., open-ended questions, acknowledging feelings, affirmations, reflective listening) to increase opportunities for and commitment to HPV vaccination while decreasing barriers (e.g., safety or access concerns).; Behavioral: Constant Component; Each participant will receive the constant component through the study website, which includes a vaccine information statement from the CDC with details on HPV vaccine benefits, potential side effects, and recommended vaccination schedule, as well as online information on access and locations for HPV vaccine (e.g., list of Vaccines for Children providers where Medicaid, uninsured, or underinsured adolescents can be vaccinated for free).
Experimental: Experimental: Exp Condition 12; Research participant receives Constant + Self-persuasion	Behavioral: Self-persuasion; Participants will complete an interactive web-based task where they audio record reasons, summarized in their own words, for getting their adolescent the HPV vaccine.; Behavioral: Constant Component; Each participant will receive the constant component through the study website, which includes a vaccine information statement from the CDC with details on HPV vaccine benefits, potential side effects, and recommended vaccination schedule, as well as online information on access and locations for HPV vaccine (e.g., list of Vaccines for Children providers where Medicaid, uninsured, or underinsured adolescents can be vaccinated for free).
Experimental: Experimental: Exp Condition 13; Research participant receives Constant + Narrative storytelling + Motivational interviewing	Behavioral: Narrative Storytelling; Participants will watch a video featuring U.S. Vietnamese parents. In the video, featured parents will describe stories of their experiences learning about the HPV vaccine as well as motivations to initiate and complete the vaccine series on-time for their adolescents.; Behavioral: Motivational Interviewing; Participants will receive 2 calls (phone or Zoom) from a trained U.S. Vietnamese health educator. The health educator will use motivation interviewing (e.g., open-ended questions, acknowledging feelings, affirmations, reflective listening) to increase opportunities for and commitment to HPV vaccination while decreasing barriers (e.g., safety or access concerns).; Behavioral: Constant Component; Each participant will receive the constant component through the study website, which includes a vaccine information statement from the CDC with details on HPV vaccine benefits, potential side effects, and recommended vaccination schedule, as well as online information on access and locations for HPV vaccine (e.g., list of Vaccines for Children providers where Medicaid, uninsured, or underinsured adolescents can be vaccinated for free).
Experimental: Experimental: Exp Condition 14; Research participant receives Constant + Narrative storytelling	Behavioral: Narrative Storytelling; Participants will watch a video featuring U.S. Vietnamese parents. In the video, featured parents will describe stories of their experiences learning about the HPV vaccine as well as motivations to initiate and complete the vaccine series on-time for their adolescents.; Behavioral: Constant Component; Each participant will receive the constant component through the study website, which includes a vaccine information statement from the CDC with details on HPV vaccine benefits, potential side effects, and recommended vaccination schedule, as well as online information on access and locations for HPV vaccine (e.g., list of Vaccines for Children providers where Medicaid, uninsured, or underinsured adolescents can be vaccinated for free).
Experimental: Experimental: Exp Condition 15; Research participant receives Constant + Motivational interviewing	Behavioral: Motivational Interviewing; Participants will receive 2 calls (phone or Zoom) from a trained U.S. Vietnamese health educator. The health educator will use motivation interviewing (e.g., open-ended questions, acknowledging feelings, affirmations, reflective listening) to increase opportunities for and commitment to HPV vaccination while decreasing barriers (e.g., safety or access concerns).; Behavioral: Constant Component; Each participant will receive the constant component through the study website, which includes a vaccine information statement from the CDC with details on HPV vaccine benefits, potential side effects, and recommended vaccination schedule, as well as online information on access and locations for HPV vaccine (e.g., list of Vaccines for Children providers where Medicaid, uninsured, or underinsured adolescents can be vaccinated for free).
Experimental: Experimental: Exp Condition 16; Research participant receives the Constant component only	Behavioral: Constant Component; Each participant will receive the constant component through the study website, which includes a vaccine information statement from the CDC with details on HPV vaccine benefits, potential side effects, and recommended vaccination schedule, as well as online information on access and locations for HPV vaccine (e.g., list of Vaccines for Children providers where Medicaid, uninsured, or underinsured adolescents can be vaccinated for free).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility: Reach	Number of enrolled participants divided by number of eligible individuals	Baseline
Feasibility: Retention	Number of of participants who drop out divided by number of randomized participants	1, 3, and 6 months post-randomization
Feasibility: Adherence	Self-persuasion task: number of web launches and length of time spent completing task; Expert video and narrative storytelling: number of views and length of engagement time; Motivational interviewing: number of completed motivational interviewing calls and length of each call	1-month post randomization
Acceptability	Survey questions and semi-structured interviews exploring cultural relevance; reason for use/lack of use; aspects participants liked the most/least; ideas for improvement	1-month post randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HPV vaccine initiation (adolescents)	Adolescent's receipt (yes or no) of ≥1 vaccine doses; uploads of adolescent vaccination cards (preferred) or self-reported if vaccination card is unavailable. Questions used: 1. You previously indicated in the baseline survey that you have a <sex - link from baseline> child aged <age - link from baseline>. Since our last survey, please indicate whether your child has gotten any HPV vaccine shot.; No; Yes 2. (if Yes to 1) If your child has received an HPV vaccine shot, you may upload a photo of your child's vaccination card or record here. This will help us confirm the information you shared. Your information will be kept confidential.	1, 3 and 6 months post-randomization
HPV vaccine intention	"How likely is it that [your adolescent] will receive HPV shots in the next 12 months?"	Baseline, 1-month, 3-month, and 6-month post-randomization
Beliefs, attitudes, and trust in HPV vaccine and childhood/adolescent vaccines	Measuring beliefs, attitudes, and trust in HPV vaccine Questions are adapted from the Human Papillomavirus (HPV)-Knowledge Scale (Kasymova et al. 2019).	Baseline, 1-month, 3-month, and 6-month post randomization
Beliefs, attitudes, and trust in other childhood/adolescent vaccines	Measuring beliefs, attitudes, and trust in other childhood and adolescent vaccines Questions are adapted from the WHO SAGE Vaccine Hesitancy Scale.	Baseline, 1-month, 3-month, and 6-month post randomization

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Milkie Vu, PhD, Northwestern University; Study Director: Namratha Kandula, Northwestern University; Study Director: Siobhan Phillips, Northwestern University; Study Director: Juned Siddique, Northwestern University

Publications and helpful links

General Publications

• Collins LM, Murphy SA, Strecher V. The multiphase optimization strategy (MOST) and the sequential multiple assignment randomized trial (SMART): new methods for more potent eHealth interventions. Am J Prev Med. 2007 May;32(5 Suppl):S112-8. doi: 10.1016/j.amepre.2007.01.022.
• Pedersen C, Petaja T, Strauss G, Rumke HC, Poder A, Richardus JH, Spiessens B, Descamps D, Hardt K, Lehtinen M, Dubin G; HPV Vaccine Adolescent Study Investigators Network. Immunization of early adolescent females with human papillomavirus type 16 and 18 L1 virus-like particle vaccine containing AS04 adjuvant. J Adolesc Health. 2007 Jun;40(6):564-71. doi: 10.1016/j.jadohealth.2007.02.015.
• Aarons GA, Sklar M, Mustanski B, Benbow N, Brown CH. "Scaling-out" evidence-based interventions to new populations or new health care delivery systems. Implement Sci. 2017 Sep 6;12(1):111. doi: 10.1186/s13012-017-0640-6.
• Lee H, Kim M, Cooley ME, Kiang PN, Kim D, Tang S, Shi L, Thiem L, Kan P, Peou S, Touch C, Chea P, Allison J. Using narrative intervention for HPV vaccine behavior change among Khmer mothers and daughters: A pilot RCT to examine feasibility, acceptability, and preliminary effectiveness. Appl Nurs Res. 2018 Apr;40:51-60. doi: 10.1016/j.apnr.2017.12.008. Epub 2017 Dec 18.
• Falcaro M, Castanon A, Ndlela B, Checchi M, Soldan K, Lopez-Bernal J, Elliss-Brookes L, Sasieni P. The effects of the national HPV vaccination programme in England, UK, on cervical cancer and grade 3 cervical intraepithelial neoplasia incidence: a register-based observational study. Lancet. 2021 Dec 4;398(10316):2084-2092. doi: 10.1016/S0140-6736(21)02178-4. Epub 2021 Nov 3.
• Kim M, Lee H, Kiang P, Allison J. Development and acceptability of a peer-paired, cross-cultural and cross-generational storytelling HPV intervention for Korean American college women. Health Educ Res. 2019 Oct 1;34(5):483-494. doi: 10.1093/her/cyz022.
• Wyrick DL, Rulison KL, Fearnow-Kenney M, Milroy JJ, Collins LM. Moving beyond the treatment package approach to developing behavioral interventions: addressing questions that arose during an application of the Multiphase Optimization Strategy (MOST). Transl Behav Med. 2014 Sep;4(3):252-9. doi: 10.1007/s13142-013-0247-7.
• Vu M, Berg CJ, Pham NT, Tiro JA, Escoffery C, Spring B, Bednarczyk RA, Ta D, Kandula NR. U.S. Vietnamese parents' trusted sources of information and preferences for intervention messaging about HPV vaccination: A mixed methods study. PEC Innov. 2023 Jul 6;3:100189. doi: 10.1016/j.pecinn.2023.100189. eCollection 2023 Dec 15.
• Jin H, Pinheiro PS, Xu J, Amei A. Cancer incidence among Asian American populations in the United States, 2009-2011. Int J Cancer. 2016 May 1;138(9):2136-45. doi: 10.1002/ijc.29958. Epub 2016 Jan 29.
• Vu M, Huynh VN, Bednarczyk RA, Escoffery C, Ta D, Nguyen TT, Berg CJ. Experience and lessons learned from multi-modal internet-based recruitment of U.S. Vietnamese into research. PLoS One. 2021 Aug 13;16(8):e0256074. doi: 10.1371/journal.pone.0256074. eCollection 2021.
• National Cancer Institute. Future Directions - Division of Cancer Control & Population Sciences. Published 2023. Accessed January 12, 2024. https://cancercontrol.cancer.gov/research-emphasis/future-directions
• National Cancer Institute. Cancer Health Disparities Research. Published 2021. Accessed September 29, 2022. https://www.cancer.gov/research/areas/disparities
• National Cancer Institute. Notice of Special Interest: National Cancer Institute Supports Applications for the Mentored Research Scientist Development Awards (K01) Within the Mission of the Division of Cancer Control and Population Sciences. Published 2023. https://grants.nih.gov/grants/guide/notice-files/NOTCA- 24-022.html
• Collins LM. Optimization of Behavioral, Biobehavioral, and Biomedical Interventions. Springer International Publishing; 2018. doi:10.1007/978-3-319-72206-1
• Lee HY, Koopmeiners JS, McHugh J, Raveis VH, Ahluwalia JS. mHealth Pilot Study: Text Messaging Intervention to Promote HPV Vaccination. Am J Health Behav. 2016 Jan;40(1):67-76. doi: 10.5993/AJHB.40.1.8.
• Ma GX, Zhu L, Tan Y, Zhai S, Lin TR, Zambrano C, Siu P, Lai S, Wang MQ. A Multilevel Intervention to Increase HPV Vaccination among Asian American Adolescents. J Community Health. 2022 Feb;47(1):9-16. doi: 10.1007/s10900-021-01013-z. Epub 2021 Jul 7.
• Chen AC, Kim WS, Todd M, Larkey L. A Digital Storytelling Intervention for Vietnamese American Mothers to Promote Their Children's HPV Vaccination. Cancer Prev Res (Phila). 2022 Jul 5;15(7):465-472. doi: 10.1158/1940-6207.CAPR-21-0618.
• Kim M, Lee H, Kiang P, Aronowitz T, Sheldon LK, Shi L, Allison JJ. A Storytelling Intervention in a Mobile, Web-Based Platform: A Pilot Randomized Controlled Trial to Evaluate the Preliminary Effectiveness to Promote Human Papillomavirus Vaccination in Korean American College Women. Health Educ Behav. 2020 Apr;47(2):258-263. doi: 10.1177/1090198119894589. Epub 2020 Jan 20.
• Lee G, Chang A, Pal A, Tran TA, Cui X, Quach T. Understanding and Addressing the Digital Health Literacy Needs of Low-Income Limited English Proficient Asian American Patients. Health Equity. 2022 Jul 4;6(1):494-499. doi: 10.1089/heq.2022.0045. eCollection 2022.
• Adia AC, Nazareno J, Operario D, Ponce NA. Health Conditions, Outcomes, and Service Access Among Filipino, Vietnamese, Chinese, Japanese, and Korean Adults in California, 2011-2017. Am J Public Health. 2020 Apr;110(4):520-526. doi: 10.2105/AJPH.2019.305523. Epub 2020 Feb 20.
• Hopfer S, Dyda A, Brandt HM. Editorial: Digital solutions to HPV vaccination. Front Digit Health. 2022 Aug 9;4:972234. doi: 10.3389/fdgth.2022.972234. eCollection 2022. No abstract available.
• Vu M, Ta D, Berg CJ, Bednarczyk RA, Huynh VN, King AR, Escoffery C. U.S. Vietnamese Mothers' HPV Vaccine Decision-Making for Their Adolescents: A Qualitative Study. J Health Care Poor Underserved. 2022;33(4):1985-2006. doi: 10.1353/hpu.2022.0149.
• Zimet GD, Silverman RD, Bednarczyk RA, English A. Adolescent Consent for Human Papillomavirus Vaccine: Ethical, Legal, and Practical Considerations. J Pediatr. 2021 Apr;231:24-30. doi: 10.1016/j.jpeds.2021.01.026. Epub 2021 Jan 20.
• Centers for Disease Control and Prevention. HPV Vaccine Recommendations. Published 2021. Accessed May 4, 2022. https://www.cdc.gov/vaccines/vpd/hpv/hcp/recommendations.html
• Pingali C, Yankey D, Elam-Evans LD, Trahan A, Markowitz LE, DeSisto CL, Hughes M, Valier MR, Stokley S, Singleton JA. Vaccination Coverage Among Adolescents Aged 13-17 Years - National Immunization Survey-Teen, United States, 2024. MMWR Morb Mortal Wkly Rep. 2025 Aug 14;74(30):466-472. doi: 10.15585/mmwr.mm7430a1.
• Vu M, Bednarczyk RA, Escoffery C, Ta D, Huynh VN, Berg CJ. U.S. Vietnamese parents' HPV vaccine decision-making for their adolescents: an exploration of practice-, provider-, and patient-level influences. J Behav Med. 2022 Apr;45(2):197-210. doi: 10.1007/s10865-021-00265-3. Epub 2021 Nov 18.
• United States Census Bureau. 2021 American Community Survey 1-Year Estimates Total Population, Vietnamese Alone or in Any Combination. Published 2021. Accessed September 28, 2022. http://data.census.gov

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2029

Study Registration Dates

• First Submitted: May 26, 2026
• First Submitted That Met QC Criteria: June 5, 2026
• First Posted (Actual): June 10, 2026

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 5, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: behavioral intervention; HPV vaccination; digital health intervention; U.S. Vietnamese; MOST framework; adolescent vaccination
• Additional Relevant MeSH Terms: Health Services; Health Care Facilities Workforce and Services; Behavioral Disciplines and Activities; Directive Counseling; Counseling; Mental Health Services; Motivational Interviewing
• Other Study ID Numbers: STU00223028; K01CA296781 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared due to the risk of re-identification. We want to protect participant confidentiality.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No